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Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF

Primary Purpose

Retinal Vein Occlusion (RVO), Macular Edema

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ozurdex implant

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion (RVO)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months.

Exclusion Criteria:

Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes
Interval surgical intervention, such as cataract surgery, that may confound visual outcomes.
Pregnancy
Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including:
Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases)
Advanced glaucoma
Aphakic eyes with rupture or missing posterior lens capsule
Eyes with anterior chamber intraocular lens and missing posterior lens capsule
Patients with known hypersensitivity to components of this product

Sites / Locations

The Retina Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ozurdex implant

Arm Description

Intravitreal injection of Ozurdex implant

Outcomes

Primary Outcome Measures

Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy

Secondary Outcome Measures

Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography

Full Information

NCT ID

NCT01946399

First Posted

September 16, 2013

Last Updated

November 29, 2017

Sponsor

Retina Research Institute, LLC

Collaborators

Retina-Vitreous Associates Medical Group, West Coast Retina Medical Group, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01946399

Brief Title

Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF

Official Title

Dexamethasone Intravitreal Implant for Retinal Vein Occlusion Associated Macular Edema After Treatment Failure With Anti-VEGF Medications

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

enrollment not met

Study Start Date

September 2013 (undefined)

Primary Completion Date

September 1, 2016 (Actual)

Study Completion Date

September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Retina Research Institute, LLC

Collaborators

Retina-Vitreous Associates Medical Group, West Coast Retina Medical Group, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response.

Detailed Description

To determine whether Ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (Avastin),ranibizumab (Lucentis), and/or aflibercept (Eylea) have not demonstrated significant response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Vein Occlusion (RVO), Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ozurdex implant

Arm Type

Other

Arm Description

Intravitreal injection of Ozurdex implant

Intervention Type

Drug

Intervention Name(s)

Ozurdex implant

Other Intervention Name(s)

Dexamethasone implant

Intervention Description

Intravitreal injection of Dexamethasone implant

Primary Outcome Measure Information:

Title

Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months. Exclusion Criteria: Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes Interval surgical intervention, such as cataract surgery, that may confound visual outcomes. Pregnancy Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including: Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases) Advanced glaucoma Aphakic eyes with rupture or missing posterior lens capsule Eyes with anterior chamber intraocular lens and missing posterior lens capsule Patients with known hypersensitivity to components of this product

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gaurav K Shah, MD

Organizational Affiliation

Retina Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Retina Institute

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF

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